Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Launched by GEORGE WASHINGTON UNIVERSITY · Jan 29, 2025

Keywords

ClinConnect Summary

The Neo-PREDICT clinical trial is studying how hormone-blocking therapy, given before surgery, affects the treatment of early-stage breast cancer (Stages I-III). This type of treatment, known as neoadjuvant endocrine therapy, helps shrink tumors before surgery. The trial aims to find out how well this therapy works and to create a way to predict how patients will respond to it based on specific test results, known as the pre-operative endocrine prognostic index (PEPI) score.

To participate in this trial, individuals should be at least 21 years old, have a confirmed diagnosis of invasive breast cancer, and be eligible for surgery. They must also have certain characteristics in their tumor, such as a specific level of estrogen receptors and being HER2 negative or low. Participants will receive the hormone therapy as part of their usual care and will provide blood and tissue samples to help researchers understand the treatment's effects. The study can last from 2 weeks to a year, depending on how long the hormone therapy is given and when surgery takes place. This trial is currently looking for volunteers, and all participants can expect regular visits and support from research staff throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
• • Be capable of signing and providing written consent in accordance with institutional and federal guidelines
• • Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
• • Clinical stage 1 to 3 breast cancer
• • Candidate for surgical resection
• • Estrogen receptor \> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
• • HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
• • Ability to take oral medication
• • Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
• • Age ≥ 21 years
• Exclusion Criteria:
• • Inability to comply taking NET
• • Inability to comply to study procedures